Global Health Centers of Excellence (GHCoE) South Africa

Collection Type
Open BioLINCC Study
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Study Period
January 2011 – March 2014 (Protocol 1); January 2012 – March 2014 (Protocol 2)

NHLBI Division
CTRIS

Date Prepared
December 11, 2017

Last Updated
N/A

Clinical Trial URLs
N/A

Primary Publication URLs
N/A

Study Website
N/A

Consent

Commercial Use Data RestrictionsNo

Data Restrictions Based On Area Of ResearchNo

Center Protocols

The South African Center of Excellence at the University of Cape Town enacted two protocols:

Protocol 1
Development and Evaluation of Tools to Manage Chronic Non-Communicable Diseases

Protocol 2
An Evaluation of Community Health Workers Screening for CVD in the Community in Four NHLBI/United Health Centers of Excellence

Objectives

Protocol 1
To enhance the identification and optimal management of chronic diseases and their risk factors in underserved communities of South Africa. Specifically:

To calibrate and validate a non-laboratory based screening tool for cardiovascular disease (CVD) risk prediction.

To evaluate the effectiveness of an integrated guideline-based training program for primary healthcare providers on the quality of care for patients with non-communicable chronic diseases.

To develop a decision analytic model of CVD in order to predict CVD events and to estimate the health and economic consequences of cardiovascular prevention interventions.

Protocol 2
To evaluate the effectiveness of training Community Health Workers (CHWs) to identify individuals at high risk for CVD in community settings in South Africa, Bangladesh, Guatemala, and Mexico using a non-lab based risk assessment tool.

Background

Protocol 1
Chronic diseases, especially cardiovascular disease (CVD), diabetes, chronic respiratory disease and certain cancers, have steadily emerged, along with mental health conditions, as major threats to health across the spectrum of Sub-Saharan Africa’s diverse racial, ethnic and social class groupings. Multiple studies in this population have shown that the common risk factors and associated elements of an unhealthy lifestyle are often undiagnosed and inadequately treated. This is especially true in public sector community health centers upon which the majority of the impoverished population rely on. The Chronic Disease Initiative in Africa proposes an integrated model for primary care of chronic disease based on World Health Organization recommendations. The goal of which is to strengthen and broaden the health care team by providing tools that improve the effectiveness of care and by mobilizing community support and patient involvement in their own care. This study addressed several aspects of this model.

Given the large global burden of CVD and very limited resources in developing countries, finding low cost prevention strategies is a top priority. In developed country cohorts, non-lab screening mechanisms have been used to predict risk of future CVD events as effectively as screenings that require blood testing. Thus, this study sought to continue with the development of a simple risk prediction tool for CVD and to assess its effectiveness in a South African cohort.

The Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) uniquely combines educational outreach, or brief onsite interactive education, with symptom-based guidelines. The program has been embedded in the South African healthcare system and shown to be effective for case management of patients with respiratory diseases and HIV/AIDS. Thus, this study sought to extend the program and evaluate if it would be effective for other major categories of chronic diseases. Furthermore, an economic evaluation model is necessary to project the implications, at both the individual and societal levels, of changes in risk factors resulting from such a program. Given that resources are limited, cost effective analysis can help compare the relative value of different options in improving the quality or length of life in order to maximize the health benefit for a given expenditure.

Protocol 2
Effective screening and appropriate management of patients who are at high risk for chronic disease in low resource settings is difficult to accomplish due to limited levels of trained personnel and limited financial resources to conduct lab-based assessments. Community Health Workers (CHWs) are important for promoting health in low socioeconomic populations, but utilization of CHWs in many low and middle income countries (LMICs) has been largely focused on infectious disease management and maternal and child health. Furthermore, the effectiveness of CHWs in screening for cardiovascular disease (CVD) risk, and referral for those at high CVD risk for care at primary health centers, has not been evaluated in LMICs. Therefore this study investigated whether training CHWs to use a non-lab based CVD risk screening tool could serve as a model for improving patient care and reducing the burden on health personnel in LMICs.

Subjects

Protocol 1
Participants were recruited from among adults attending 38 clinics in the Eden and Overberg districts of the Western Cape. The majority of patients seeking care from these public sector clinics are poor and from the underserved sectors of the South African population. The CVD risk screening tool validation study included adults at least 35 years of age and with no history of cardiovascular events. The integrated care guideline trial included adults at least 18 years of age meeting one of the following criteria: (1) self-reported treatment for diabetes, (2) self-reported treatment for hypertension, (3) self-reported treatment for asthma, chronic bronchitis, or emphysema, (4) coughing or difficulty breathing for at least two weeks and no treatment for tuberculosis within the past three months, or (5) the Center for Epidemiologic Studies Depression Scale (CES-D 10 Scale) score of 10 or more.

Protocol 2
At least ten CHWs were recruited from each site. CHWs were selected from individuals employed or actively collaborating with the local health authorities in the communities where screening was to occur. They were required to speak the local language and have a minimal level of education specified by each country.

Screening participants included men and women at least 25 years of age who were present in the community of each site. Exclusion criteria included not being able to speak or understand the CHW’s language, having a history of treatment for hypertension or diabetes, known CVD, or systolic blood pressure ≥ 180 mmHg.

Design

Protocol 1
The study consisted of three components: (1) a validation study of a non-laboratory based tool to predict risk of future cardiovascular events, (2) a trial testing the effectiveness of a novel training approach to the management of chronic diseases by primary care nurses and doctors, and (3) development of an economic model that could estimate the cost-effectiveness of CVD interventions.

Eligible participants were selected from patients receiving consultation at a participating clinic, and could be enrolled in the validation study, the trial, or both, depending on eligibility. Participants underwent blood pressure, waist and hip circumference, height, and weight measurements, and participated in an interview to determine care received at the clinic, symptom severity, impact on their quality of life, healthcare utilization, and the costs incurred by illness. A portion of the participants also provided a blood sample for the measurement of HbA1C . Participants qualifying for the trial were asked to return to the clinic 12-15 months later for a follow-up interview.

The primary outcome of the validation study was all cause mortality and CVD mortality. A national mortality registry was used to identify events.

The integrate care guideline trial randomized clinics to two parallel arms. Usual training and support for chronic diseases continued in both groups, including use of the Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) as a training tool for case management based on syndromic guidelines. Maintenance of PALSA PLUS training continued throughout the trial in the control group. Nurse managers at the intervention clinics were equipped as outreach trainers for ongoing PALSA PLUS maintenance and for the training of staff in the expanded chronic disease content. The primary endpoint for diabetes, hypertension and chronic respiratory disease was treatment intensification. The primary endpoint for depression was case detection.

Protocol 2
This was a pilot study to test the effectiveness of training CHWs in South Africa, Bangladesh, Guatemala, and Mexico to use a non-lab CVD screening tool. The selected CHWs underwent a training session to educate them about CVD risk factors and how to use the risk assessment tool. There were pre- and post-training assessments of their knowledge of CVD and its risk factors. Assessments were repeated three months after completion of the community screening to test retention of knowledge.

The trained CHWs recruited and screened participants in a community setting over the course of four to six weeks. Blood pressure, height, weight, demographics, and medical history were recorded. After screening and calculating the risk score, the CHW inform the participant of their possible risk level and referred high risk individuals to schedule a visit with a trained health professional at the clinic. Risk scores were also calculated by a health professional using the recorded data. Any disagreement between the CHW and health professional’s assessment of risk was reviewed by the site investigator. At one and six months after the screening, a study assistant reviewed clinic appointments to determine which high risk participants referred to the clinic had scheduled and completed the visit.

Study outcomes included the percent agreement between CHW-generated risk scores and trained health professional-generated risk scores, the proportion of high risk participants who obtained a referral for a clinic visit, the proportion of referred high risk patients who scheduled and attended a clinic visit, and CHW knowledge level of CVD risk factors after training in the use of the risk prediction tool.

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Study Documents

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